Air-in-Line Alarms During Antineoplastic Drug Infusion (AIR-ONC)

Innovation in Antineoplastic Drug Infusion: A Multiphase Observational Study of Air-in-Line Alarms, Safety, and Therapeutic Continuity

The goal of this observational study is to evaluate infusion alarms, particularly air-in-line alarms, during antineoplastic drug infusion in oncology care settings.

The main questions it aims to answer are:

How frequently do infusion alarms occur, and what types of alarms are observed during antineoplastic drug infusion? How long does it take healthcare professionals to manage infusion alarms and restore infusion continuity? What strategies do healthcare professionals use to manage infusion alarms? How do healthcare professionals evaluate the user experience of different infusion technologies?

Participants will be healthcare professionals involved in antineoplastic drug infusion. They will not receive any experimental intervention. Researchers will observe routine infusion procedures and collect data on alarm events, alarm management, infusion technologies, and user experience.

Study Overview

• Status: Not yet recruiting
• Conditions: Medication Safety; Infusion Safety; Antineoplastic Drug Administration; Air-in-Line Alarm
• Intervention / Treatment: Other: Routine Infusion Technologies

Detailed Description

ntravenous administration of antineoplastic drugs represents a complex and high-risk clinical process. Antineoplastic agents are classified as high-alert medications because administration errors may lead to severe clinical consequences. One of the most relevant operational issues in infusion oncology practice is the occurrence of air-in-line alarms, which may interrupt drug administration, increase healthcare professionals' workload, and negatively affect therapeutic continuity. This issue may be particularly relevant with foaming drugs, which are more likely to generate microbubbles within infusion lines.

Despite the clinical relevance of infusion alarms, current literature does not provide robust real-world evidence regarding their prevalence, associated factors, or comparative performance of different infusion technologies in oncology settings. Furthermore, limited evidence is available regarding healthcare professionals' operational management of infusion alarms and user experience associated with infusion devices.

The present study is designed as a multicenter, prospective, observational, multiphase and multimethod study integrating three complementary methodological phases.

Phase 1 consists of a controlled preclinical simulation study using standardized foaming preparations and infusion systems to evaluate the occurrence of air-in-line alarms under simulated conditions.

Phase 2 consists of a prospective field observational study aimed at evaluating healthcare professionals' practices during antineoplastic drug infusion and infusion alarm management in real-world oncology settings. This phase applies the Entrustable Professional Activities framework to identify key professional competencies related to infusion safety and alarm management.

Phase 3 consists of a prospective multicenter observational cohort study aimed at collecting real-world data regarding infusion alarms, alarm management time, operational strategies, and healthcare professionals' user experience with infusion technologies routinely used in clinical practice.

The study does not include experimental interventions, treatment allocation, or modifications to standard clinical practice. All infusion technologies included in the study are CE-marked medical devices routinely used in participating centers according to their intended purpose. No patient clinical data will be collected. Data collection will focus on infusion-related technical events, organizational variables, observable professional behaviors, and healthcare professionals' user experience.

The study will be conducted in five Italian oncology centers and is expected to last approximately 24 months following ethics approval and local authorization procedures. Data will be collected and managed using the REDCap electronic data capture platform. Statistical analyses will include descriptive and inferential methods aimed at identifying factors associated with infusion alarm occurrence, alarm management, and user experience outcomes.

The results of this study are expected to contribute to the development of evidence-based recommendations for safer infusion practices, optimization of oncology infusion workflows, and improvement of healthcare professionals' training related to infusion technologies and alarm management.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Rosario Caruso, PhD, RN, FESNO, FAAN; Phone Number: + 39 02503 15119; Email: rosario.caruso@unimi.it
• Study Contact Backup: Name: Greta Ghizzardi, PhD, RN; Phone Number: +39 0371376565; Email: greta.ghizzardi@asst-lodi.it

Study Locations

• Italy
  • Emilia-Romagna
    • Parma, Emilia-Romagna, Italy, 43126
      • AUSL Parma
      • Contact: Marco A Arcidiacono, RN, MSN; Phone Number: +39 347 5255859; Email: marcoalfredo.arcidiacono@unipr.it
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Fondazione Policlinico Universitario A. Gemelli IRCCS
      • Contact: Monica Liberatori, RN, MSN; Phone Number: +39 06 3015 4275; Email: monica.liberatori@policlinicogemelli.it
  • Lombardy
    • Lodi, Lombardy, Italy, 26900
      • ASST Lodi
      • Contact: Greta Ghizzardi, PhD, RN; Phone Number: + 39 0371376565; Email: greta.ghizzardi@asst-lodi.it
    • Milan, Lombardy, Italy, 20132
      • IRCCS Ospedale San Raffaele
      • Contact: Anna Carmagliola, RN, MSN; Phone Number: + 39 02.26431; Email: carmagnola.anna@hsr.it
    • Milan, Lombardy, Italy, 20141
      • IEO - Istituto Europeo di Oncologia
      • Contact: Giorgio Magon, RN, MSN; Phone Number: +39 02 574891; Email: giorgio.magon@ieo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Healthcare professionals involved in routine intravenous administration of antineoplastic drugs in participating oncology centres. The study will observe routine infusion procedures to evaluate infusion alarms, alarm management strategies, adherence to infusion safety practices, and user experience with infusion technologies. Infusion procedures constitute the primary unit of observation, while healthcare professionals constitute the study participants.

Description

Inclusion Criteria:

• Healthcare professionals involved in the administration of antineoplastic drugs in participating oncology centres.
• Employment in a participating study site during the study period.
• Direct involvement in routine intravenous antineoplastic drug infusion procedures.
• Participation in infusion procedures eligible for observation according to the study protocol.

Exclusion Criteria:

• Healthcare professionals not directly involved in antineoplastic drug administration.
• Healthcare professionals working outside participating study sites.
• Temporary staff not routinely involved in infusion activities during the observation period.
• Refusal to participate in study activities where local regulations require participant notification.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthcare Professionals Involved in Antineoplastic Drug Infusion; Healthcare professionals involved in routine antineoplastic drug infusion procedures in participating oncology centers. Participants will be observed during routine clinical practice to evaluate infusion alarms, alarm management strategies, infusion safety practices, and user experience with infusion technologies.	Other: Routine Infusion Technologies; Observation of routinely used infusion technologies and infusion-related alarm management during standard antineoplastic drug administration in oncology care settings. No experimental intervention or treatment allocation is performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and Type of Infusion Alarms	Number and type of infusion alarms, including air-in-line alarms, recorded during simulated and real-world antineoplastic infusion procedures.	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to Evidence-Based Infusion Safety Practices	Observed adherence to predefined safety behaviors and procedures during antineoplastic drug infusion and infusion alarm management.	Up to 24 months
User Experience With Infusion Technologies	Healthcare professionals' user experience scores regarding usability, alarm clarity, perceived safety, workload, confidence, and overall satisfaction with infusion devices.	Up to 24 months
Operational Strategies for Infusion Alarm Management	Strategies adopted by healthcare professionals to manage infusion alarms and maintain or restore infusion continuity during antineoplastic drug administration.	Up to 24 months
Alarm Management Time	Time in minutes required to manage infusion alarms and restore infusion continuity.	Up to 24 months
Inter-Center Variability in Alarm Management	Variability in alarm frequency, alarm management time, and operational strategies across participating oncology centers.	Up to 24 months
Factors Associated With Alarm Occurrence and Management	Clinical, technological, and organisational factors associated with infusion alarm occurrence, alarm management time, and user experience indicators.	Up to 24 months

Collaborators and Investigators

• Sponsor: Associazione Italiana Infermieri di Area Oncologica
• Collaborators: University of Milan; IRCCS Multimedica

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: July 16, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Antineoplastic agents; Infusion pumps; User experience; High-alert medications; Oncology nursing; Air-in-line alarms; Infusion safety; Alarm management; Entrustable Professional Activities
• Other Study ID Numbers: AIIAO-AIRINLINE-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No